Clinical Trials at Northern Westchester Hospital
At Northern Westchester Hospital, we are committed to providing leading-edge treatments and clinical trials close to home. Our patients can benefit from major medical advancements previously found in big city hospitals, now in the comfort of our own community.
Click on a link below to view clinical trials at Northern Westchester Hospital:
- Bariatric Surgery
- Brain Tumor
- Breast Cancer
- Cancer - ALL Solid Tumor
- Colorectal Cancer
- Lung Cancer
- Prostate Cancer
We continue to expand the availability of clinical trials in Westchester, New York and Fairfield, CT. For more information on Northern Westchester Hospital Clinical Trials, click CONTACT US on the left, or call the Clinical Trials Director, Dr. Joshua Fink, at 914.666.1366.
SIPS Procedure CLOSED to new enrollment
What: A prospective multi-center single-arm study of the Stomach, Intestinal and Pylorus Sparing Procedure (SIPS)
Who: Subjects who have elected to undergo bariatric surgery using the SIPS procedure (according to subject and investigator assessment and standard of care).
Why: The primary objective of this study is to evaluate excess weight loss at 12 months following the SIPS Procedure. SIPS is a single-anastomosis duodenal-intestinal switch procedure. Preliminary data from Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. CovidienTM plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the SIPS procedure. Click here to learn more about the SIPS procedure.
What: The DCVax-L study is evaluating an experimental vaccine for its effectiveness in treating Glioblastoma brain tumors.
Who: This study is designed for patients diagnosed with a Glioblastoma tumor – a specific type of cancerous brain tumor.
Why: The DCVax-L study is evaluating an experimental vaccine derived from a patient’s own white blood cells that is believed to work with the patient’s immune system to target brain cancer cells.
NCT00892177 / N0872 CLOSED to new enrollment
What: Phase I and Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma.
Who: This study is designed for men and women who are 18 years or older with histological confirmation of grade 3 or 4 glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review; Note: Variant gliosarcomas are eligible.
Why: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.
Join Us: To see if you, or someone you may know, fit the criteria for the brain tumor clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
What: The SOLAR-1 study is a phase III randomized double-blind, placebo controlled study of Alpelisib in combination with Fulvestrant (Faslodex®) for men and postmenopausal women with hormone receptor positive (ER/PR), HER2(-) negative advanced breast cancer which progressed on or after aromatase inhibitor treatment.
Who: This study is designed for men and postmenopausal women who are 18 years or older with hormone receptor positive (ER/PR), HER2(-) advanced breast cancer, which progressed on or after Aromatase Inhibitor treatment.
Why: The purpose of this study is to assess the efficacy and safety by determining whether treatment with Alpelisib plus Fulvestrant prolongs progression-free survival (PFS) compared to Fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (ER/PR), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo) adjuvant or for advanced disease.
Takeda (C31006) OPEN
What: The C31006 study is an open-label phase 2 study of MLN0128 (A TORC1/2 Inhibitor) in combination with Fulvestrant in women with ER-Positive/HER2 Negative advanced or metastatic breast cancer that has progressed during or after aromatase inhibitor therapy. Fulvestrant will be used in combination with daily MLN0128, weekly with MLN0128, or alone without MLN0128 in women with advanced or metastatic breast cancer after aromatase inhibitor therapy.
Who: This study is designed for postmenopausal women who are 18 years or older with advanced or metastatic ER-positive/HER2-negative breast cancer who have progressed on or after Aromatase Inhibitor treatment.
Why: This phase 2, open-label, randomized, 3-arm study is designed to evaluate the efficacy and safety of the combination of Fulvestrant + daily MLN0128 compared with single-agent Fulvestrant, and the combination of Fulvestrant + weekly MLN0128 compared with single-agent Fulvestrant in the treatment of postmenopausal women with advanced or metastatic (ER) positive, (HER2) negative breast cancer that has progressed during or after aromatase inhibitor (AI) therapy.
NSABP B47 CLOSED to new enrollment
What: The NSABP B47 study is a trial of adjuvant therapy comparing chemotherapy alone to chemotherapy plus trastuzumab in women with node-positive or high-risk node-negative HER2-low-invasive breast cancer.
Who: This study is designed for women who are 18 years or older that are not pregnant or nursing. To be eligible, the patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy) (patients who have had a nipple-sparing mastectomy are eligible).
Why: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread and others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer. The purpose of this study is to determine if adding a targeted therapy, trastuzumab, to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
Paloma-2 (Formerly A5481008) CLOSED to new enrollment
What: The Paloma-2 study is a randomized, multicenter, double-blind Phase 3 study of Letrozole plus PD-0332991 versus Letrozole plus Placebo for the treatment of postmenopausal women with ER(+), HER2(-) Breast Cancer who have not received any prior systemic anti-cancer treatment for advanced disease.
Who: This study is designed for postmenopausal women who are 18 years or older with ER(+), HER2(-) locoregionally recurrent or metastatic disease and will be candidates to receive Letrozole as first-line treatment for their advanced disease.
Why: This study is being done to confirm the clinical benefit and superiority of the combination of PD-0332991 and Letrozole compared to Letrozole and Placebo in postmenopausal women with ER(+)/HER2(-) locoregionally recurrent or metastatic breast cancer
Paloma-3 (Formerly A5481023) CLOSED to new enrollment
What: The Paloma-3 study is a multicenter, randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of PD-0332991 (Palbociclib) in combination with Fulvestrant (Faslodex®) over Fulvestrant alone in prolonging Progression Free Survival (PFS) in women with hormone receptor positive (ER/PR), HER2(-) locally recurrent or metastatic breast cancer whose disease progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared.
Who: This study is designed for women who are 18 years or older with hormone receptor positive (ER/PR), HER2(-) locally recurrent or metastatic breast cancer whose disease progressed after prior endocrine therapy.
Why: This study is comparing the effects and demonstrating superiority between the two treatment arms in preventing further cancer growth. It will also study the safety of the study treatment.
Join Us: To see if you, or someone you may know, fit the criteria for the breast cancer clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
What: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Who: Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement as determined by any nucleic acid-based diagnostic testing method (e.g., NGS, Sanger, RTPCR, NanoString, EdgeSeq; FISH is not an acceptable method) performed at a local CLIA-certified or equivalently-accredited diagnostic laboratory.
Why: To determine the objective response rate (ORR) of entrectinib, as assessed by BICR, in each patient population basket of solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement.
Unknown Primary Cancer Clinical Trials New York
What: The TEMPO study is a prospective observational trial evaluating outcomes of FoundationOne®-Directed Matched Targeted Therapy in patients with Cancer of Unknown Primary (CUP).
Who: Patients with a histologically or cytologically confirmed diagnosis of metastatic or advanced unresectable cancer of unknown primary including adenocarcinoma, poorly differentiated adenocarcinoma, poorly differentiated carcinoma, or squamous carcinoma. To be categorized as CUP, the following clinical evaluations must have been performed without identification of an anatomic primary site: medical history, physical examination, chemistry profile, blood counts, serum PSA (men), CT scans of chest/abdomen/pelvis, specific evaluation of symptomatic areas.
Why: The primary feasibility objective of this study is to determine the utility of comprehensive molecular profiling via FoundationOne® in identifying molecular abnormalities in CUP patients that direct therapy with matched targeted agents. The primary efficacy objective of this study is to demonstrate an improvement in overall survival (OS) in a predefined subset of CUP patients receiving matched targeted therapy based on FoundationOne® versus a historical control.
Join Us: To see if you, or someone you may know, fit the criteria for cancer clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
XBIOTECH CLOSED to new enrollment
What: The XBIOTECH study is a phase-III double-blinded, placebo controlled study of Xilonix™ for improving survival in metastatic colorectal cancer.
Who: Patients with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with at least all of the following agents: oxaliplatin, irinotecan, flouropyrimidine, and cetuximab or panitumumab if KRAS wild type.
Why: The purpose of this study is to assess the efficacy and safety by determining whether treatment with Xilonix prolongs progression-free survival (PFS).
What: An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations
Who: Subjects with locally advanced, metastatic or unresectable Stage IIIB/IV adenocarcinoma NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R) who have not previously been treated with an EGFR inhibitor (1st line).
Why: This multinational, open-label randomized study will evaluate ASP8273 compared to erlotinib or gefitinib (1st generation EGFR TKI) as first line therapy in subjects with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R) who have not previously received an EGFR inhibitor. The primary objective is to evaluate the progression-free survival for the two groups.
INCYTE 18424-266 (NCT02119650) CLOSED to new enrollment
What: This is a double-blind Phase II randomized study of Ruxolitinib or Placebo in combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for initial treatment of subjects with Nonsquamous Non-Small Cell Lung Cancer (NSCLC) that is stage IIIB, stage IV, or recurrent.
Who: This study is designed for both men and women between the ages of 18 and 75 with histologically or cytologically confirmed diagnosis of nonsquamous NSCLC.
Why: Part 1: To determine of the dose of Ruxolitinib that is safe and tolerable in combination with Pemetrexed/Cisplatin as measured by the number of dose-limiting toxicities (DLTs); Part 2: To track overall survival.
CheckMate 153 (CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 153) CLOSED to new enrollment
What: A phase IIIb/IV safety trial of nivolumab (BMS-936558).
Who: Patients with Stage IIIB, Stage IV, or with recurrent or progressive disease following multi-modal therapy (radiation therapy, surgery, or chemo-radiotherapy for locally advanced disease).
Why: The main objective of the study is to provide additional insight into the frequency of high-grade select adverse events and their outcome, and thus supplement the growing safety database of nivolumab-treated patients.
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST A151216) OPEN
What: The study seeks EGFR and ALK genotyping of non-squamous non-small cell lung cancer tissue.
Who: The study is designed for patients 18 years or older with no malignancies in the past five years, except non-melanoma skin cancer.
Why: To centrally genotype lung surgery patients for EGFR mutations and ALK rearrangements in order to develop adjuvant studies; advanced genomic analyses in conjunction with the NCI Center for Cancer Genomics (CCG).
ALCHEMIST A081105 OPEN
What: This is a randomized double blind placebo controlled study of ERLOTINIB or placebo in patients with completely resected epidermal growth factor receptor (EGFR), mutant non-small cell lung cancer (NSCLC).
Who: For patients who have gone through the ALCHEMIST Screening Trial A151216 (above) at first for the EGFR exon 19 deletions or L858R mutation.
Why: To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (≥4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.
ALCHEMIST E4512 OPEN
What: This is a phase III double-blind trial for surgically resected early stage non-small cell lung cancer: Crizotinib versus placebo for patients with tumors harboring the anaplastic lymphoma kinase (ALK) fusion protein.
Who: For patients who have gone through the ALCHEMIST Screening Trial A151216 (above) and determined to be ALK positive; and patients with Stage IB (≥ 4 cm)/II/IIIA NSCLC complete surgical resection.
Why: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB ≥ 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.
Join Us: To see if you, or someone you may know, fit the criteria for lung cancer clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
informCLL (PCYC-1134M) OPEN
What: informCLL™: A Disease Registry for Patients with Chronic Lymphocytic Leukemia. This study is a post-marketing/phase IV observational clinical trial.
Who: Patients with CLL/SLL who are initiating novel therapies including approved oral kinase inhibitors, or patients initiating other approved anti-CLL therapies/regimens for the treatment of CLL/SLL.
Why: To describe current treatment patterns in the real-world setting among CLL patients who are initiating treatment with novel therapies including approved oral kinase inhibitors or other approved anti-CLL therapies/regimens as first- or later-line therapy, and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.
Join Us: To see if you, or someone you may know, fit the criteria for clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
HOMER OMB113676 CLOSED to new enrollment
What: A phase III randomized, open label study of single agent ofatumumab versus single agent rituximab in the treatment of indolent B-cell non-Hodgkin's lymphoma, relapsed after rituximab-containing therapy.
Who: This study is designed for adults 18 years or older with:
- lymphoma Grades 1, 2, 3 A
- Small lymphocytic lymphoma (SLL)
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
Why: Rituxan (rituximab) is the current standard of care for patients with slow-growing lymphomas, such as non-Hodgkin's lymphoma. Although Rituxan is a highly targeted and well-tolerated lymphoma treatment, the remission rate is lower. Ofatumumab has induced remissions in patients with similar conditions, but has not yet been studied in lymphoma. The HOMER study seeks to determine whether ofatumumab alone can achieve improved outcomes.
CALGB 50901 CLOSED to new enrollment
What: The CALGB trial is a Phase II randomized trial comparing the use of high and low doses of ofatumumab for previously untreated patients with follicular non-Hodgkin’s lymphoma to determine whether higher or lower doses can achieve improved outcomes in patients with low-grade follicular NHL.
Who: This study is designed for adults 18 years or older with follicular non-Hodgkin’s lymphoma who have been previously untreated. Those that are pregnant or nursing are not eligible.
MEAL – Men's Eating and Living CLOSED to new enrollment
What: The MEAL study, sponsored by the National Cancer Institute, focuses on whether a man's nutrition and diet can contribute towards the progression of prostate cancer.
Who: The MEAL study is designed for men who have been diagnosed with prostate cancer and have been placed on active surveillance, also known as the watch and wait approach. These men have not had chemotherapy, radiation or surgery.
Why: The MEAL study is designed to test whether a high-vegetable diet will lower the risk for prostate cancer progression compared to a “standard” diet. The MEAL study is crucial to our understanding of the possible relation between consumption of foods and food groups and the progression of prostate cancer.
Join Us: To see if you, or someone you may know, fit the criteria for the MEAL prostate cancer clinical trial, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
POINT : Platelet-Oriented Inhibition in New TIA, and minor ischemic stroke CLOSED to new enrollment
What: A prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.
Who: Patients 18 years of age or older with high-risk TIA, or minor ischemic stroke, who can be randomized within 12 hours of time last known free of new ischemic symptoms.
Why: To determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events.
ORBIT AFib II : Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II CLOSED to new enrollment
What: A phase ll trial designed to evaluate target-specific anti-thrombotic agents and direct thrombin inhibitors, and associated outcomes.
Who: Adults, 21 years of age and older, with AF (atrial fibrillation) diagnosed within the preceding 6 months; or (2) have initiated or transitioned to a FXa inhibitor or a direct thrombin inhibitor within the preceding 3 months.
About The Clinical Trials Program at NWH
Joshua Fink, MD, is the Medical Director of the Clinical Trials Program at Northern Westchester Hospital, Mt. Kisco, NY.
Jonathan Goldberg, MD, is the Medical Director of the Cancer Clinical Trials at the Cancer Treatment and Wellness Center at Northern Westchester Hospital.
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